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Feasibility of FMISO in Brain Tumors

ConditionIDH Wild Type Glioblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute

About this trial

This phase II trial studies how well 18F- fluoromisonidazole (FMISO) works with positron emission tomography (PET)/magnetic resonance imaging (MRI) in assessing participants with malignant (cancerous) brain tumors. Two contrast agents called gadolinium and ferumoxytol are used during some of the MRI scans. A contrast agent is a liquid-like dye that is given intravenously (IV) to help imaging machines create pictures. The study drug, called FMISO, provides information about the oxygen levels in a tumor, which may affect how the tumor behaves. PET/MRI imaging produces images of the brain and how the body functions. FMISO PET/MRI may help investigators see how much oxygen is getting in the brain tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (18 years of age and older) with a clinically suspected glioma

Able to provide informed written consent and/or acceptable surrogate capable of providing consent on the patient's behalf

Legally authorized representative (LAR)-signed informed consent and assent obtained for those subjects identified as decisionally impaired

Intracranial disease greater than 5 mL as assessed by T2/fluid attenuated inversion recovery (FLAIR) MR imaging

Disqualifiers

Pregnant or breastfeeding.

Contraindication to PET, MRI, FMISO, ferumoxytol, or intravenous gadolinium based contrast agents.

Claustrophobia is not controlled with medical therapy

Weight is greater than modality maximum capacity.

Trial design

Design model

Single group

Treatments tested in this trial

  • ¹⁸F-Fluoromisonidazole

    Drug

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo PET/MRI or PET/CT

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/MRI

  • Oxygen Therapy

    Procedure/Surgery

    Receive supplemental oxygen

  • Ferumoxytol

    Drug

    Given IV

  • Gadolinium

    Drug

    Given IV

Treatment groups

77 Participants
are divided into 1 treatment group
Group A: Diagnostic (FMISO, PET/MRI or PET/CT)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Successful production of images

Assessed as a factor of generating quantitative positron emission tomography (PET)/magnetic resonance imaging (MRI) metrics (intra-tumoral FMISO tumor to blood \[T/B\] level, hypoxic volume, dynamic susceptibility contrast enhanced \[DSC\], diffusion-weighted imaging \[DWI\], and segregation \& extravascular localization of ferumoxytol imaging \[SELFI\] values, and tissue oxygen maps). Images generated during the administration of oxygen will be used to generate tissue oxygen maps of the brain. Following completion of cohort enrollment, the generation of each quantitative PET/MRI metric will be independently scored as a dichotomous variable; successful or non-successful. Proportional assessment will be performed to assess for project feasibility. The estimated proportion of success rate for each metric along with the corresponding 95% binomial confidence interval will be provided.

Time frame
Two days of diagnostic imaging
2

SELFI and hypoxic fraction, and T1 ferumoxytol Fe/gadolinium (Gd) log mismatch ratio in patients receiving immunotherapy

Diagnostic performance of PET/MRI metrics (SELFI and hypoxic fraction) and Gd\_MRI to differentiate progression from neuroinflammation (pseudoprogresion) will be evaluated using sensitivity, specificity and area under the receiver operating curve (AUROC). Sensitivity and specificity will be characterized using proportions and exact 95% confidence intervals. Difference in diagnostic performance between PET/MRI metrics (SELFI and hypoxic fraction) and Gd\_MRI will be assessed using McNemar's test to compare sensitivity and specificity and using the DeLong test to compare AUROC.

Time frame
Two days of diagnostic imaging at time of suspected progression
3

SELFI and hypoxic fraction, and T1 ferumoxytol Fe/gadolinium (Gd) log mismatch ratio in all patients

Diagnostic performance of PET/MRI metrics (SELFI and hypoxic fraction) and Gd\_MRI to differentiate progression from neuroinflammation (pseudoprogresion) will be evaluated using sensitivity, specificity and AUROC. Sensitivity and specificity will be characterized using proportions and exact 95% confidence intervals. Difference in diagnostic performance between PET/MRI metrics (SELFI and hypoxic fraction) and Gd\_MRI will be assessed using McNemar's test to compare sensitivity and specificity and using the DeLong test to compare AUROC.

Time frame
Two days of diagnostic imaging at time of suspected progression

Secondary outcomes

1

Successful co-registration (Yes vs. No)

The generation of co-registered imaging data sets will be independently scored as a dichotomous variable; successful or non-successful (\< 10mm versus \[vs.\] \> 10mm alignment error). Proportional assessment will be performed to assess for project feasibility. The estimated proportion along with the corresponding 95% binomial confidence interval will be provided.

Time frame
Baseline to the start of long-term follow-up (up to 5 years)
2

T/B value and hypoxic tumor volume

Tumor-to-background ratio (TBR) is calculated by dividing the tumor SUV by the mean SUV of the background region, using either voxelwise values or summary measures such as SUVmean. To define hypoxic volume, a threshold-based approach is applied in which all tumor voxels with FMISO uptake above a predetermined TBR cutoff are classified as hypoxic; the hypoxic volume is then calculated as the total volume of these above-threshold voxels. Hypoxic volume is measured in mm3.

Time frame
Time Frame: Baseline to the start of long-term follow-up (up to 5 years)
3

Generation of SELFI Metric

Will assess generation of whole brain SELFI MRI data set. Generation of SELFI MRI: YES/NO.

Time frame
Imaging time points before gadolinium-based contrast agent defined presumed progression, year 1-4
4

SELFI diagnostic performance of imaging metrics

SELFI metric will be assessed to identify failed therapy at each imaging timepoint. Assessing Failed Therapy: Area Under the Curve for each metric at each time point to diagnose disease progression

Time frame
Imaging time points before gadolinium-based contrast agent defined presumed progression, year 1-4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OHSU Knight Cancer Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Oregon Health and Science University

Collaborator

Source ClinicalTrials.gov
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